MEPs back new guidelines to fix women's clinical trial gaps
A European Parliament committee has backed proposals to mandate gender-sensitive clinical trials and boost research funding, responding to data showing women are diagnosed with cancer two-and-a-half years later than men.
On 23 June, the European Parliament’s committee on women’s rights and gender equality (FEMM) passed a report demanding a structural overhaul of medical research and diagnostics across the bloc. The proposals passed 27 to nine, with opposition coming entirely from rightwing and far-right groups, including the ECR, Patriots for Europe, and Europe of Sovereign Nations.
The legislative push targets systemic flaws that carry significant costs for European healthcare systems and the pharmaceutical industry. Billy Kelleher, the Irish Renew Europe MEP who led the negotiations, highlighted a critical metric of these failures: cancer in women is diagnosed two-and-a-half years later than in men. Such delays inevitably result in more complex treatments and higher systemic costs.
A primary focus of the report is the regulation of clinical trials. Historically, medicine has been a "male-dominated preserve" where academic priorities were male-centric. Kelleher argued this legacy persists today, as trials routinely exclude pregnant or breastfeeding women. "We can't assume that if something is safe for men, it is automatically safe for women," he said.
To address this, the report calls on the European Medicines Agency to draft new guidelines. The recommendations demand better inclusion rates, mandated sex-disaggregated data, and gender-sensitive research design throughout the entire research cycle. "We can't simply dismiss entire population groups without valid evidence that the risks justify doing so," Kelleher added, noting that experts rather than arbitrary exclusions must weigh efficacy and risk factors.
If ratified at the plenary session, likely in September, these measures would require drug developers to significantly alter trial structures. While mandating broader population cohorts could increase research costs for pharmaceutical companies, it would also provide the industry with much-needed data on drug safety and efficacy for women.
Beyond trial design, the report addresses a chronic funding shortfall in gender-specific healthcare research. For Europe’s medical sector and public health systems, the vote signals a political push to dismantle long-standing gender biases in both scientific funding and clinical practice.
